Federal Register / Vol. 70, No.
215 / Tuesday, November 8, 2005 / Notices
Proximal Anastomotic Assist Devices
Surgeons use proximal AADs in
CABG procedures to avoid the need to
clamp the aorta when attaching a
harvested vessel to it. If a proximal AAD
is not used, the surgeon must use a
clamp to stop the flow of blood to a
segment of the aorta while the harvested
vessel is surgically attached. Using a
clamp can cause calcified plaque
particles to dislodge from the aorta and
travel through the blood stream to the
brain, risking neurological dysfunction
or stroke.
The proper geographic market in
which to analyze the effects of the
proposed transaction on the market for
proximal AADs is the United States.
Proximal AADs are medical devices that
must be approved by the FDA before
being marketed in the United States. As
with other medical devices, the clinical
testing and regulatory approval process
for proximal AADs can be costly and
time-consuming, preventing proximal
AADs approved outside of the United
States but not approved within the
United States from serving as a
competitive alternative for U.S.
consumers.
There are currently three firms in the
U.S. market for proximal AADs, making
it a highly concentrated market. The
evidence indicates that J&J and
Guidant’s manual proximal AADs are
each others’ closest competitors.
Medtronic also participates in the
market with an automatic device that it
recently launched in the United States.
A fourth firm, St. Jude Medical,
removed its automatic device,
Symmetry, from the market last year
amidst reports of device failures. J&J’s
proximal AAD, eNclose, was
developed and is manufactured by
Novare; J&J and Novare have a
distribution agreement making J&J the
sole distributor of eNclose in the
United States.
As with the other medical devices
discussed, entry into the market for
proximal AADs is difficult, costly, and
time-consuming. Additionally, the
alleged safety concerns regarding St.
Jude’s Symmetry device have resulted
in greater scrutiny of proximal AADs by
the FDA. The increased scrutiny is
likely to substantially increase the cost
of developing a proximal AAD. In
addition, it appears that the publicity
surrounding Symmetry’s removal from
the market has dampened physician
enthusiasm for these devices. These
developments, along with the declining
number of overall U.S. CABG
procedures, decrease the likelihood of
entry into this market.
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The proposed acquisition is likely to
cause significant competitive harm in
the market for proximal AADs by
eliminating competition between J&J
and Guidant and reducing the number
of competitors in the market from three
to two. The evidence has also shown
that J&J and Guidant’s products are
likely each others’ closest competitors
in the proximal AAD market because
they are more similar to each other than
to Medtronic’s product. The proposed
acquisition is therefore likely to enable
the combined J&J/Guidant to raise prices
for proximal AADs unilaterally.
The proposed acquisition’s
anticompetitive effects in the market for
proximal AADs are remedied by the
proposed Consent Agreement’s
requirement that J&J terminate its
distribution agreement with Novare for
Novare’s proximal AAD, eNclose. It is
anticipated that it will take Novare no
more than two months to find a new
distribution partner for eNclose.
Appointment of an Interim Monitor and
a Divestiture Trustee
The proposed Consent Agreement
contains a provision that allows the
Commission to appoint an interim
monitor to oversee J&J’s compliance
with all of its obligations and
performance of its responsibilities
pursuant to the Commission’s Decision
and Order. The interim monitor is
required to file periodic reports with the
Commission to ensure that the
Commission remains informed about
the status of the divestitures, about the
efforts being made to accomplish the
divestitures, and the provision of
services and assistance during the
transition period for the EVH
divestiture.
Finally, the proposed Consent
Agreement contains provisions that
allow the Commission to appoint a
divestiture trustee if any or all of the
above remedies are not accomplished
within the time frames required by the
Consent Agreement. The divestiture
trustee may be appointed to accomplish
any and all of the remedies required by
the proposed Consent Agreement that
have not yet been fulfilled upon
expiration of the time period allotted for
each.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Decision
and Order or to modify its terms in any
way.
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By direction of the Commission, with
Chairman Majoras and Commissioner
Harbour recused.
Donald S. Clark,
Secretary.
[FR Doc. 05–22165 Filed 11–7–05; 8:45 am]
BILLING CODE 6750–01–P
GOVERNMENT ACCOUNTABILITY
OFFICE
Advisory Council on Government
Auditing Standards; Notice of Meeting
The Advisory Council on Government
Auditing Standards will meet Monday,
December 5, 2005, from 8:30 a.m. to 5
p.m., in room 7C13 of the Government
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Street, NW., Washington, DC.
The Advisory Council on Government
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government auditing standards. The
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Any interested person who plans to
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ybk01.htm) one week prior to the
meeting for a final agenda.
Jeanette M. Franzel,
Director, Financial Management and
Assurance.
[FR Doc. 05–22205 Filed 11–7–05; 8:45 am]
BILLING CODE 1610–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
AGENCY: Department of Health and
Human Services (HHS) Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of
Records (SOR).
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to establish a new
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